BUPROPION HYDROCHLORIDE tablet, film coated, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)

Tilgjengelig fra:

Anchen Pharmaceuticals, Inc.

INN (International Name):

BUPROPION HYDROCHLORIDE

Sammensetning:

BUPROPION HYDROCHLORIDE 150 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Bupropion hydrochloride extended-release tablets (SR) are indicated as an aid to smoking cessation treatment. Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients with a seizure disorder. Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients treated with WELLBUTRIN (bupropion hydrochloride), the immediate-release formulation; WELLBUTRIN SR (bupropion hydrochloride), the sustained-release formulation; WELLBUTRIN XL (bupropion hydrochloride), the extended-release formulation; or any other medications that contain bupropion because the incidence of seizure is dose dependent. Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa because of a higher incidence of seizures noted in patients treated for bulimia with the immediate-release formulation of bupropion. Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients undergoing

Produkt oppsummering:

Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg of bupropion hydrochloride, are purple, round-shaped, film-coated tablets engraved with “A204” in bottles of 60 (NDC 10370-204-06) tablets and in bottles of 1000 (NDC 10370-204-00) tablets. Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F) (see USP). Dispense in tight, light-resistant containers as defined in the USP. WELLBUTRIN® and WELLBUTRIN XL® are registered trademarks of GlaxoSmithKline. KALETRA® is a registered trademark of Abbott Laboratories.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

BUPROPION HYDROCHLORIDE - BUPROPION HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
Anchen Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Bupropion Hydrochloride Extended- Release Tablets USP (SR)
Read this Medication Guide carefully before you start using bupropion
hydrochloride extended-release
tablets (SR) and each time you get a refill. There may be new
information. This information does not take
the place of talking with your doctor about your medical condition or
your treatment. If you have any
questions about bupropion hydrochloride extended-release tablets (SR),
ask your doctor or pharmacist.
IMPORTANT: Be sure to read the three sections of this Medication
Guide. The first section is about the
risk of changes in thinking and behavior, depression and suicidal
thoughts or actions with medicines used
to quit smoking; the second section is about the risk of suicidal
thoughts and actions with antidepressant
medicines; and the third section is entitled “What Other Important
Information Should I Know About
Bupropion Hydrochloride Extended-Release Tablets (SR)?”
Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and
Behavior, Depression, and
Suicidal Thoughts or Actions
This section of the Medication Guide is only about the risk of changes
in thinking and behavior
depression and suicidal thoughts or actions with drugs used to quit
smoking.
Some people have had changes in behavior, hostility, agitation,
depression, suicidal thoughts or actions
while taking bupropion hydrochloride extended-release tablets (SR) to
help them quit smoking. These
symptoms can develop during treatment with bupropion hydrochloride
extended-release tablets (SR) or
after stopping treatment with bupropion hydrochloride extended-release
tablets (SR).
If you, your family member, or your caregiver notice agitation,
hostility, depression, or changes in
thinking or behavior that are not typical for you, or you have any of
the following symptoms, stop taking
bupropion hydrochloride extended-release tablets (SR) and call yo

Preparatomtale

BUPROPION HYDROCHLORIDE - BUPROPION HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
ANCHEN PHARMACEUTICALS, INC.
----------
BUPROPION HYDROCHLORIDE EXTENDED RELEASE TABLETS USP (SR)
“MEDICATION GUIDE” ENCLOSED
WARNING
Serious neuropsychiatric events, including but not limited to
depression, suicidal ideation, suicide
attempt, and completed suicide have been reported in patients taking
bupropion hydrochloride
extended-release tablets (SR) for smoking cessation. Some cases may
have been complicated by
the symptoms of nicotine withdrawal in patients who stopped smoking.
Depressed mood may be a
symptom of nicotine withdrawal. Depression, rarely including suicidal
ideation, has been reported
in smokers undergoing a smoking cessation attempt without medication.
However, some of these
symptoms have occurred in patients taking bupropion hydrochloride
extended-release tablets (SR)
who continued to smoke.
All patients being treated with bupropion hydrochloride
extended-release tablets (SR) should be
observed for neuropsychiatric symptoms including changes in behavior,
hostility, agitation,
depressed mood, and suicide-related events, including ideation,
behavior, and attempted suicide.
These symptoms, as well as worsening of preexisting psychiatric
illness and completed suicide
have been reported in some patients attempting to quit smoking while
taking bupropion
hydrochloride extended-release tablets (SR) in the post-marketing
experience. When symptoms
were reported, most were during treatment with bupropion hydrochloride
extended-release
tablets (SR), but some were following discontinuation of treatment
with bupropion hydrochloride
extended-release tablets (SR).
These events have occurred in patients with and without pre-existing
psychiatric disease; some
have experienced worsening of their psychiatric illnesses. Patients
with serious psychiatric
illness such as schizophrenia, bipolar disorder, and major depressive
disorder did not participate
in the pre-marketing studies of bupropion hydrochloride
extended-release